MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 1999-01-28 for TROPHOCAN CVS CATHETER 4870-26 manufactured by Sims Portex, Inc..
[174363]
The pt underwent the "cvs" procedure and one transcervical pass was made. No villi was found in the sample and the pt reported an amniotic fluid leak 2-3 days post procedure. The pt experienced a spontaneous pregnancy loss several weeks later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217052-1999-00003 |
| MDR Report Key | 207849 |
| Report Source | 00,05 |
| Date Received | 1999-01-28 |
| Date of Report | 1998-12-29 |
| Date Mfgr Received | 1998-12-29 |
| Date Added to Maude | 1999-01-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TROPHOCAN CVS CATHETER |
| Generic Name | CATHETER, SAMPLING, CHORIONIC VILLUS |
| Product Code | LLX |
| Date Received | 1999-01-28 |
| Model Number | NA |
| Catalog Number | 4870-26 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 201729 |
| Manufacturer | SIMS PORTEX, INC. |
| Manufacturer Address | 10 BOWMAN DR. KEENE NH 03431 US |
| Baseline Brand Name | TROPHOCAN CVS CATHETER |
| Baseline Generic Name | CATHETER, SAMPLING, CHORIONIC VILLUS |
| Baseline Model No | NA |
| Baseline Catalog No | 4870-26 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | Y |
| Premarket Approval | P8900 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-01-28 |